Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surgery.
Recall
- Recall Number
- Z-1847-2015
- Event Number
- 71342
- Firm
- Medtronic Navigation, Inc.
- FEI Number
- 1000517638
- Product Code
- HAW
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- May 26, 2015
- Posted
- June 26, 2015
- Terminated
- October 23, 2015
- Address
- 826 Coal Creek Cir, Louisville, CO, 80027-9710
Description
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surgery.
Medtronic Navigation is initiating a field correction due to the potential for injury which could occur as a result of cleaning the Medtronic Navigated Cannulated Taps.
Consignees were notified via Urgent Medical Device Correction Notification on 5/26/15. The letter identified the affected product and described the issue. This field correction does not require the return of the subject products. Revised instructions for use are being provided to the identified consignees.
Worldwide Distribution.
15,798